German biotechnology company BioNTech SE and Shanghai Fosun Pharmaceutical (Group) Co Ltd jointly announced on Wednesday that their lead mRND COVID-19 vaccine candidate BNT162b2 will be evaluated in a phase 2 clinical trial.
The phase 2 clinical trial will be carried out in Taizhou and Lianshui of East China's Jiangsu province. Jiangsu Provincial Center for Disease and Prevention will be responsible for the trial.
The online recruitment of volunteers will commence with the recruitment of 960 healthy participants, aged between 18 and 85, to assess the safety and immunogenicity of the vaccine candidate and to support future biologic license applications in China.
In the ongoing phase 3 clinical study of the vaccine, BNT162b2 met all primary efficacy endpoints, with an efficacy rate of 95 percent in preventing symptomatic COVID-19 infections. Sufficient safety data was collected to support the submission of an emergency use authorization to the US Food and Drug Administration on Nov 20. In addition, BNT162b2 is currently under regulatory review by regulatory authorities in Europe, the United Kingdom and Canada.
According to Ugur Sahin, CEO and co-founder of BioNTech, the clinical trial research carried out in China is an important part of the global research and development of the company's COVID-19 vaccine and marks an important step in bringing this vaccine to the people of China.
On March 13, Fosun Pharma became the strategic partner of BioNTech in China, jointly developing and commercializing vaccine products for COVID-19 based on its proprietary mRNA technology platform in China. Apart from discussing the research and development plans with partners and completing clinical trials in China, Fosun Pharma has also designed and completed animal challenge trials of selected mRNA vaccines, including BNT162b2, in collaboration with Chinese research institutes, and shared outcomes with partners in a timely manner.
Hui Aimin, chief medical officer of Fosun Pharma, said that the COVID-19 pandemic proves once again that global cooperation is needed to control infectious diseases.
"As an important part of global research and development, the phase two clinical study with BNT162b2 in China will not only provide key data for the launch of the vaccine in China, but also may play a positive role in the widespread promotion and use of the vaccine throughout Asia and around the world," he said.
Fosun Pharma announced on Wednesday a private placement plan in the A-share market. The financing value is estimated at around 4.98 billion yuan ($758.25 million), which will be mainly used for the development, commercial license and introduction permits of innovative drugs, including the development of the highly anticipated mRNA COVID-19 vaccine.
